BURMEIER
ARMINIA II Model 51.3431.33S Instruction Manual Edition March 2004
Instruction Manual
46 Pages
Preview
Page 1
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1 = head board (wooden sections) 2 = side guard 3 = handset 4 = release buttons for side guards 5 = foot 6 = castor 7 = mains cable holder 8 = location (both sides) of sleeves for patient’s lifting pole at mattress base frame
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Contents 1
Foreword
2
General 2.1
3
...5 Information
...6
Definition of the Groups of Persons Involved
2.2
Safety
Information
2.2.1
Explanation
2.2.2
Safety
Information
for
the
2.2.3
Safety
Information
for
the
2.3
Product
...
7
...
8
Safety
...
8
...
9
...
10
...
12
Use
...
12
Features
...
13
of
the
Description
Symbols
Used
Operator User
2.3.1
Designated
2.3.2
Special
2.3.3
Materials
Used
...
13
2.3.4
Structural
Design
...
13
Assembly 3.1
and
Putting
Assembly
into
Service
...15
...
15
3.1.1
Assembly
of
the
Mattress
Base
...
16
3.1.2
Assembly
of
the
bed
...
17
3.1.3
Assembly
of
the
Side
3.2
Electrical
Connection
3.2.1
Plug
Assignment
3.3
Putting
into
Strain
Relief
3.3.2
Location
3.3.3
Operational
...
19
...
20
Control
...
21
...
21
...
22
of
the
Service
3.3.1
Guards
Requirements Readiness
Unit
...
23
...
24
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3.4
Dismantling
3.5
Storage
24
...
25
Dolly
4
Operation...26 4.1
Special Safety Information for the Drive Unit System ...
26
4.2
Handset
...
27
4.2.1
Using
the
Handset
28
4.3
Handset
with
Blocking
4.3.1
Blocking
4.3.2
Using
4.4
Castors
4.5
Mains
4.6
Patient’s
Lifting
4.7
Lower
Leg
4.8
Side
Guards
4.9
Emergency
5
... Function
function
31
...
32
Holder
...
Pole
33
...
34
...
34
Lowering
of
the
and
Disinfection...38
Information
5.2
Cleaning
and
Disinfection
5.3
Instructions
for
the
5.4
Cleaning
and
5.4.1
Handling
Disinfection
By
the
User
...
Instructions
37
38
...
39
and
Expert
...
39
Disinfection
Agents
...
40
Agents
...
41
...42 ...
Operator
Trouble-Shooting
Backrest
...
User
Maintenance
6.2
32
...
Rest
(accessory)
General
the
29
...
handset
5.1
By
...
30
Cable
6.1
(Accessory)
...
the
Cleaning
6
7
...
...
43 44
...45
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Dear Customer, BURMEIER would like to thank you for the confidence you have placed in us and our products in deciding to purchase this Arminia II nursing bed. Each bed has been tested by the manufacturer for electrical safety and functionality and has left our factory in perfect condition. This instruction manual informs you as the operator and your users about all the functions necessary to ensure ease of operation and safe handling of this bed on a daily basis. You should, therefore, also regard this instruction manual as a practical reference book to be kept near the bed and at hand at all times. We wish you and your users every success in care-giving. We are confident that this product enables us to play an important role in achieving just that. Burmeier GmbH & Co. KG
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The nursing bed ARMINIA II is manufactured in various model versions. This instruction manual has been issued for several bed types. It is possible that certain functions or features are described which are not incorporated in your model. Overview of the ARMINIA II bed models:
Before using the nursing bed for the first time: • Read through this instruction manual from start to finish so as to prevent damages due to incorrect operation. • Clean and disinfect the nursing bed prior to first-time use. Before using a nursing bed, the user must check that the bed is fully functional and in perfect working order as well as follow the instruction manual in accordance with the MedizinprodukteBetreiberverordnung (German abbreviation: MPBetreibV, Operators of Medical Products Ordinance) § 2. The same applies for accessories. This nursing bed fulfils all the requirements of the 93/42/EWG directive for medical products. It is classified as a class 1 active medical product in accordance with the Medizinproduktegesetz (German abbreviation: MPG § 13, Medical Products Act). The nursing bed ARMINIA II has been inspected by TÜV (German abbreviation for Technischer Überwachungsverein, Technical Inspection Authority). Any piece of technical equipment, electrical or otherwise, can prove hazardous if not properly operated. Please also pay attention to your obligations as the operator in accordance with the MPBetreibV (Operators of Medical Products Ordinance), in order to ensure a permanent safe operation of this medical product with no risk of danger to patients, users and third parties. This instruction manual contains safety information which must be followed. All users working on and with the nursing bed must be familiar with the contents of this instruction manual and follow the safety advice provided.
Instructions for the Operator: . • Any piece of technical equipment, electrical or otherwise, can prove hazardous if not properly operated. You are
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obligated to instruct users in the proper use of this nursing bed in accordance with MPBetreibV § 5 (Operators of Medical Products Ordinance). . • Ensure that users know where this instruction manual is located in accordance with MPBetreibV § 9 (Operators of Medical Products Ordinance). 2.1 DEFINITION OF THE GROUPS OF PERSONS INVOLVED In this instruction manual, the following groups of persons are defined as: Operator Operators (e. g.: medical suppliers, medical specialists, medical insurance providers) are every natural and legal person who use the ARMINA II Nursing Bed or by whose orders the bed is used. The operator is obliged to properly instruct users. User Users are persons who, on the basis of their training, experience or through instruction, are entitled to operate the ARMINA II Nursing Bed or to carry out work on it. Users have received instruction in the handling of this bed. Futhermore, they are able to recognise and avoid possible hazards as well as assess the clinical condition of the patient. Patient In this instruction manual, a patient is defined as a person who is infirm, disabled or in need of care and occupies this bed. Expert Experts are defined as employees of the operator who, on the basis of their training or through instruction, are entitled to deliver, assemble, dismantle and transport the nursing bed. Furthermore, they have been instructed in the regulations regarding cleaning and disinfection.
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2.2 SAFETY INFORMATION At the time of leaving the factory, the nursing bed ARMINIA II represents state-of-the-art technology and has been TÜV inspected (German abbreviation for Technischer Überwachungsverein, Technical Inspection Authority). • Use the ARMINIA II Nursing Bed only if you are absolutely certain that it is in perfect working order. The most important objective of the safety information is to prevent personal injuries. 2.2.1 Explanation of the Safety Symbols Used In this instruction manual, the following safety symbols are used. Warning of personal injury This symbol indicates hazards due to electrical voltages. There is danger to life. This symbol indicates general hazards. There is danger to life and health. Warning of damage to property This symbol indicates possible damages to property. It is possible that damages to the drive unit, material or the environment may occur. Other advice This symbol indicates a generally useful tip. If you follow it, you will find it easier to operate the bed. Moreover, this tip is provided for your better understanding. The respectively used safety symbol is not a substitute for the written safety information. Therefore read the safety information and follow it precisely!
2.2.2 Safety Information for the Operator
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• Using this instruction manual, which must be provided with the bed, ensure that every user is instructed in the safe operation of this bed before using for the first time. Draw every user’s attention to the possible hazards that can arise if the bed is improperly used. This applies in particular to the use of electrical drives and side guards. • Nursing beds are classified as a class 1 active medical product in accordance with the Medizinproduktegesetz (Medical Products Act). Therefore, in order to ensure permanent safe operation of this medical product with no risk to patients, users and third parties, observe your obligations in accordance with the Medizinprodukte-Betreiberverordnung (Operators of Medical Products Ordinance). If the bed is in long-term use, test the functions and check for visual damages (see chapter 6) after a reasonable period of time (recommendation: every 6 months). • Only permit persons who have been properly instructed to use this bed. • Make sure that substitute staff are also sufficiently well instructed in the safe operation of the bed. • When other additional equipment (e.g. compressors for positioning systems, etc.) is attached, ensure that all equipment is safely mounted and functioning. Pay special attention to: o safe hook-up of all loose connector cables, tubing, etc. o no multiple socket outlets are located under the bed (fire hazard in the presence of penetrating fluids). o chapter 2.3.1 of this instruction manual. In the case of ambiguity, consult the manufacturer of the additional equipment or BURMEIER. • Check that your staff are complying with the safety information.
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2.2.3 Safety Information for the User • Ensure that the operator instructs you in the safe operation of this bed.
• Each time before using the nursing bed, check that it is in perfect working order. • Ensure that no obstacles such as furniture or sloped ceilings could impede adjustments to the bed. • When using external electrical components such as patient lifts, reading lamps, or compressors for positioning systems, ensure that all equipment mains cables will not become entangled or damaged by the moving parts of the bed. • Multiple socket outlets should not be used to connect external electrical components. • If any damage or malfunction is suspected, unplug immediately from the mains supply, indicate clearly that the nursing bed is “Out of Order” and take it out of service. Report this immediately to the operator responsible.
A check list for assessing the proper condition of the bed is given in chapter 6.1
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2.3 PRODUCT DESCRIPTION 2.3.1 Designated Use • The ARMINIA II Nursing Bed, hereafter referred to as the bed, was developed as a comfortable solution for the home care of infirm or disabled persons in need of care. It should support this care. • This bed is not designed for use in hospitals. • This bed can be used to care for a patient under a doctor’s instructions and serve for diagnosis, treatment or observation of the patient. For this reason, a handset with blocking functions is available as an accessory (see chapter 8). • This bed has no special connectors for potential equalisation. Please pay attention to this before connecting with additional electrical (medical) equipment. If necessary, further information on additional protective measures can be found: o in the instruction manuals of these additional electrical devices (e.g. compressed air positioning systems, infusion pumps, enteral feeding devices ...) o in the DIN EN 60601-1-1:2002 standard (Sicherheit vom medizinischen elektrischen Systemen, Safety for Electromedical Systems) o in the VDE 0107:1994 standard (Starkstromanlagen in Krankenhäusern, High Voltage Installations in Hospitals) • The safe working load (SWL) of this bed is 1700 N (~175 kg), based on a patient weight of 135 kg. The remaining 40 kg are distributed over the mattress and mounted accessories. • This bed is not suitable for patients with a height of less than 150 cm. Please refer to the safety information provided in chapter 4.8, especially for patients in poor clinical condition. • This bed may be operated only by persons who have received instruction in its safe operation. • This bed is suitable for repeated use. When reusing beds, pay attention to the necessary requirements: o Cleaning and Disinfection (see chapter 5) o Maintenance / Repeat Inspections (see chapter 6.2) This bed may only be operated according to the conditions described in this instruction manual. Any other use shall be regarded as non-compliant with the
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regulations.
2.3.2 Special Features Electrical height adjustment of the mattress base between approx. 40 and 80 cm. Electrical adjustment of the backrest between 0° and approx. 70°. Electrical adjustment of the thigh rest between 0° and approx. 35°. Electrical tilting of the mattress base into the prone position to approx.10°. Moveable via four, individually-locking castors. Mattress base 200 x 90 cm, in four sections; external dimensions approx. 220 x 102 cm. Side guards for both sides, can be lowered. 2.3.3 Materials Used For the most part, the bed was manufactured from steel profiles whose surfaces were finished with a polyester powder coating or a metal coating of zinc or chromium. The head and foot boards, side guard bars and wooden spring slats are wood or wood products whose surfaces have been finished. All surfaces are recognised as being safe for contact with skin. 2.3.4 Structural Design The bed is delivered unassembled in order to make it transportable into any home. It consists of two headboards (wooden sections), a head section, a foot section, a mattress base frame that can be separated in the middle, four side guard bars and a patient's lifting pole with a grab handle (accessory, included in delivery). The bed is equipped with four individually-locking castors. A storage dolly can also be supplied. Mattress Base The mattress base is divided into a backrest, a fixed middle part and a thigh rest. The rests are adjustable. The mattress base can be adjusted horizontally in height or to a prone position. All adjustments are performed by electric motors using a handset. Side Guards In order to prevent the patient from inadvertently falling out of the bed, the bed has side guards on both sides which serve as a barrier when raised or can be lowered when not needed. The locking
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mechanism is secure and can only be released when the side guard is slightly lifted.
Electrical Adjustment System The electrical drive system for this bed is fault-secure, flame-retardant (V0) and consists of: the electronic control unit. The control unit generates, via a transformer, a 24 Volt protective low voltage which is nonhazardous for patients and users. All electric motors and the handset are connected to the central control unit and operate on the generated 24 Volt protective low voltage. electric motors for the back and thigh rests. two electric motors for height adjustments to the mattress base. a handset with a stable hook. a handset with a stable hook and blocking function (accessory). The user can block handset adjustments when necessary due to the poor clinical condition of the patient.
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- Upon delivery the bed is packed or mounted on a storage dolly. The operator’s experts assemble the bed on site. The assembly should be carried out by two people. • Remove all packaging materials and cable bindings. Packing units Box 1: mattress base complete with electrical motors 4 side guard bars patient's lifting pole with grab handle Box 2: 2 head boards Box 3: head and foot section with electric motors, plastic sliders and screws 3.1 ASSEMBLY • If the nursing bed is delivered mounted on a storage dolly (see chapter 3.5), the mattress base is provided unassembled and needs to be assembled. • If the bed is delivered packed, the mattress base is provided preassembled. • Since the bed can be tilted into the prone position, it is important that the head and foot boards are not mixed up! In order to correctly identify and position the head/foot boards, the following stickers are found in the middle of the cross tubing by the head/foot boards near the motor connector mount and in the middle of the cross tubing of the mattress base frame.
Headboard sticker at the head end of the bed
Footboard sticker at the foot end of the bed
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3.1.1 Assembly of the Mattress Base • Remove the side guards and patient’s lifting pole from the storage dolly. (see chapter 3.5). These parts will be assembled later. • Remove both mattress base parts from the storage dolly. • Rest the head section of the mattress base on end on the floor; sleeves for patient's lifting pole on the lower end. • Unscrew the two knurled screws found on each side of the foot section of the mattress base. • Place the foot section of the mattress base onto the head section as far as it will go. • Hand-tighten the four knurled screws on the joint piece. • Connect the motor lifting bar with the connector mounts of the head section of the mattress base. To do this, insert the locking pin through the connector Mount and lifting bar and secure in place by flipping the clamp around. • Lay the mattress base frame flat on the floor.
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3.1.2 Assembly of the bed . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . .
• Lay the mattress base frame flat on the floor. • Unscrew the knurled screws at the head of the bed. • Raise the mattress base frame at the head end of the bed. Slide the connecting piece on the headboard into the mattress base frame until the mattress base frame is adjacent to the corner posts. Pay attention to matching stickers! • Hand-tighten the knurled screws on both sides.
• Repeat the assembly procedure for the footboard.
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.
• Attach the head boards to the head and foot sections one after the other and press them down as far as they will go.
• Use the Spax screws to fasten the head boards through the catch.
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3.1.3 Assembly of the Side Guards At all four bed corners there is a guide rail in the head/foot boards for the side guards. • Slip one plastic slider upwards into each guide rail of the head section. • The plastic sliders must always be inserted into the guide rails such that their pointed ends point upwards. • Press the lower release button first to negotiate the blocking. Then proceed pushing the plastic slider further up until you reach the upper release button. • Then press the top release button and push the plastic slider another approx. 5 cm further up. • Release the release button and lower the slider slowly until it safely locks into place. • Insert the side guard bar onto the mounted plastic slider. The rounded edge of the bar should be up. Note: the bars have different heights. The higher of the two bars (8 cm) must occupy the upper position!
. . . .
8 cm
. . . . . . . . . Page 19 of 46
• Insert another plastic slider (tip pointing upwards) into the other end of the bars. Press the lower release button and move the plastic slider up in the guide rail of the footboard. • Assemble the second side guard in the same manner.
• Check the remaining distance between the end of the bar and the guide rail does not exceed 10 mm. If necessary, reduce this distance by pushing the corner posts further into the mattress base. (see chapter 3.1.2). max. 10 mm 3.2 ELECTRICAL CONNECTION In order to use the bed with all electrical adjusting functions you have to connect the plugs of the electric motors to the control unit.
• Run the motor and handset cables underneath the mattress base frame. • Insert the right angle plug for the height adjustment motor by the headboard and clip the strain relief in. • Insert the right angle plug for the height adjustment motor by the footboard and clip the strain relief in.
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